GxP Compliance

Leading global services for cGxP compliance needs

GMP / GDP Compliance

We want to be sure that we understand your needs, in order to support, protect and help you thrive in all markets.
Our aim is to help you be stronger and fitter. Our customized and cost-effective solutions for Quality (beyond compliance) are a competitive advantage; as being non-compliant is an expense that no company can afford. PQE’s commitment is to help our customers identify problems with a proactive attitude, before they arise; this commitment will guide you to make your processes smarter and more efficient.
Overall we will support you to find the most sustainable way to develop practical and tailored plans that align global quality capabilities with your business strategy.

Pharmaceutical (GMP & GDP)
Capabilities
  • Compliance Strategies
  • Continuous Improvement and Performance Metrics Implementation
  • Risk Management Implementation
  • Quality System Implementation (Corporate Policies and Local SOPs)
  • Quality Structures (QC, QA, RA) Assessments for Skills and Staffing
  • Inspection Readiness Master Plans (FDA, EU, ANVISA, CFDA, PMDA, TGA, COFEPRIS and other regulatory bodies)
  • Mock Inspections and Assistance During Inspections/Post-Inspection
  • Supplier Management and Monitoring Strategies
  • Training Systems Implementation / Mentoring / Coaching
  • Retrospective Review of Production Data
  • Training in GMP/GDP Compliance and Topical Matters
  • Support in critical event management (complaints, deviations, sterility failures, recalls)
  • Pharma Organizational Change Management Support
  • CAPA System Implementation
  • Annual Product Review support
  • Sterility Assurance
  • Improving Quality and reducing defects – Six-Sigma
Life Science Quality (Medical Devices)
Capabilities
  • 21 CFR 820 compliance
  • ISO 13485 compliance
  • MDSAP Compliance & Validation Support
  • Notified Bodies Audits & FDA Inspections Support
  • Mock Inspections
  • DHF, DMR, DHR creation and review
  • Quality Policies & Manual, Standard Operating Procedures
  • Documentation Management
  • CAPA and Complaints management system implementation
  • Vigilance and MDR system implementation
  • Risk Management, Usability Support
  • MD Software Life validation

Clinical & MD Vigilance Compliance

PQE provides flexible solution for clinical evaluation of medical devices and for clinical investigation carried out in human subjects.
In order to deliver leading GCP services to PQE clients, our consultants practice the most innovative Quality by Design and Quality Risk Management approaches related to clinical studies. PQE can support the implementation of a MD Vigilance quality system, starting from the compliance assessment of “AS-IS” scenario, which involves document editing and the quality system deployment at corporate or local level.

Clinical Capabilities (Medical Devices)
  • Auditing service (qualification of suppliers and specific audit to data and/or documents – Follow-up, For Cause‚Ķ i.e. CROs, Investigational Sites, Centralized Laboratories)
  • SOPs/Policies Development, Issuing and Review
  • Process Mapping
  • Trainings
  • Data management
  • Quality management
  • Clinical evaluation management
  • ISO 14155 compliance
  • CER preparation
MD Vigilance Capabilities (Medical Devices)
  • Auditing service (suppliers qualification and over-sight, specific audit to data and/or documents)
  • Quality Management and SOPsMD Vigilance

Training & Knowledge Transfer Excellence Center

PQE offers cost effective practical training courses based on latest industry guidance, regulations and real life experience.
All courses are full of examples, case studies, and are held by our top class executive consultants.
Courses can be organized both at fundamental and advanced levels based on the following topics:

Available Courses (Pharma)
  • Computer System Validation (GAMP, 21CFR Part 11, IT Infrastructure)
  • FDA Inspection Readiness
  • Quality Management System
  • Process Equipment, Laboratory Equipment & Utilities Qualification
  • Process Validation
  • Analytical Methods Validation
  • Regulatory Affairs
  • Risk management
  • Systems Implementation, Mentoring & Coaching
  • GMP/GDP Compliance & Topical Matters
  • GCP Compliance & Clinical Trials
  • Process Analytical Technology
  • Technology Transfer
  • Pharmacovigilance Compliance & PV Operations
Available Courses (Medical Devices)
  • Computer System Validation (GAMP, 21CFR Part 11, IT infrastructure)
  • ISO 13485 compliance
  • New MDR 2017/745, 2017/746
  • MDSAP Model
  • FDA Inspection Readiness
  • Design control & Change
  • Medical Device Reporting
  • CAPA & Complaints Management
  • Quality Management System
  • Process Equipment Qualification
  • Laboratory Equipment Qualification
  • Process Validation
  • Analytical Methods Validation
  • Medical Device Directives
  • Regulatory Affairs
  • Risk Management
  • ISO14155 Compliance and clinical evaluation
  • Technology Transfer